THE CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 2010 
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ARRANGEMENT OF SECTIONS 
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CHAPTER I 

PRELIMINARY 

SECTIONS 

1.  Short title, application and commencement. 
2.  Definitions. 

CHAPTER II 

THE NATIONAL COUNCIL FOR CLINICAL ESTABLISHMENTS 

3.  Establishment of National Council. 
4.  Disqualifications for appointment as member. 
5.  Functions of National Council. 
6.  Power to seek advice or assistance. 
7.  National Council to follow consultative process. 

REGISTRATION AND STANDARDS FOR CLINICAL ESTABLISHMENTS 

CHAPTER III 

8.  State Council of clinical establishments. 
9.  Providing information to National Council. 
10.  Authority for registration. 
11.  Registration for clinical establishments. 
12.  Condition for registration. 
13.  Classification of clinical establishments. 

CHAPTER IV 

PROCEDURE FOR REGISTRATION 

14.  Application for provisional certificate of registration. 
15.  Provisional certificate. 
16.  No inquiry prior to provisional registration. 
17.  Validity of provisional registration. 
18.  Display of certificate of registration. 
19.  Duplicate certificate. 
20.  Certificate to be non-transferable. 
21.  Publication of expiry of registration. 
22.  Renewal of registration. 
23.  Time limit for provisional registration. 

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SECTIONS 

24.  Application for permanent registration. 
25.  Verification of application. 
26.  Display of information for filing objections. 
27.  Communication of objections. 
28.  Standards for permanent registration. 
29.  Allowing or disallowing of registration. 
30.  Certificate of permanent registration. 
31.  Fresh application for permanent registration. 
32.  Cancellation of registration. 
33.  Inspection of registered clinical establishments. 
34.  Power to enter. 
35.  Levy of fee by State Government Appeal. 
36.  Appeal. 

CHAPTER V 

REGISTER OF CLINICAL ESTABLISHMENTS 

37.  Register of clinical establishments. 
38.  Maintenance of State Register of clinical establishments. 
39.  Maintenance of National Register of clinical establishments. 

CHAPTER VI 

PENALTIES 

40.  Penalty. 
41.  Monetary penalty for non-registration. 
42.  Disobedience of direction, obstruction and refusal of information. 
43.  Penalty for minor deficiencies. 
44.  Contravention by companies. 
45.  Offences by Government Departments. 
46.  Recovery of fine. 

CHAPTER VII 

MISCELLANEOUS 

47.  Protection of action taken in good faith. 
48.  Furnishing of returns, etc. 
49.  Power to give directions. 
50.  Employees of the authority, etc., to be public servants. 
51.  Power to remove difficulties. 
52.  Power of Central Government to make rules. 
53.  Laying of rules. 
54.  Power of State Government to make rules. 
55.  Laying of rules. 
56.  Savings. 

THE SCHEDULE. 

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THE CLINICAL ESTABLISHMENTS (REGISTRATION AND 
REGULATION) ACT, 2010 

ACT NO. 23 OF 2010 

[18th August, 2010.] 

An Act to provide for the registration and regulation of clinical establishments in the country and 

for matters connected therewith or incidental thereto. 

WHEREAS,  it  is  considered  expedient  to  provide  for  the  registration  and  regulation  of  clinical 
establishments  with  a  view  to  prescribe  minimum  standards  of  facilities  and  services  which  may  be 
provided by them so that mandate of article 47 of the Constitution for improvement in public health may 
be achieved; 

ANDWHEREAS, Parliament has no power to make laws for the States with respect to any of the matters 

aforesaid except as provided in articles 249 and 250 of the Constitution; 

ANDWHEREAS,  in  pursuance  of  clause  (1)  of  article  252  of  the  Constitution,  resolutions  have  been 
passed  by  all  the  Houses  of  the  Legislatures  of  the  States  of  Arunachal  Pradesh,  Himachal  Pradesh, 
Mizoram  and  Sikkim  to  the  effect  that  the  matters  aforesaid  should  be  regulated  in  those  States  by 
Parliament by law; 

BE it enacted by Parliament in the Sixty-first Year of the Republic of India as follows:— 

CHAPTER I 

PRELIMINARY 

1.  Short  title,  application  and  commencement.—(1)  This  Act  may  be  called  the  Clinical 

Establishments (Registration and Regulation) Act, 2010. 

(2) It applies, in the first instance, to the whole of the States of Arunachal Pradesh, Himachal Pradesh, 
Mizoram and Sikkim and the Union territories; and it shall apply to such other State which adopts this 
Act by resolution passed in that behalf under clause (1) of article 252 of the Constitution. 

(3) It shall come into force at once in the States of Arunachal Pradesh, Himachal Pradesh, Mizoram 
and  Sikkim  and  the  Union  territories,  on  such  date  as  the  Central  Government  may,  by  notification, 
appoint and in any other State which adopts this Act under clause (1) of article 252 of the Constitution, on 
the date of such adoption; and any reference in this Act to the commencement of this Act shall, in relation 
to any State or Union territory, mean the date on which this Act comes into force in such State or Union 
territory: 

Provided that different dates may be appointed for different categories of clinical establishments and 

for different recognised systems of medicine. 

2. Definitions.—In this Act, unless the context otherwise requires,— 

(a) “authority” means the district registering authority set-up under section 10; 

(b) “certificate” means certificate of registration issued under section 30; 

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(c) “clinical establishment” means— 

(i) a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution 
by whatever name called that offers services, facilities requiring diagnosis, treatment or care for 
illness,  injury,  deformity,  abnormality  or  pregnancy  in  any  recognised  system  of  medicine 
established  and  administered  or  maintained  by  any  person  or  body  of  persons,  whether 
incorporated or not; or 

(ii)  a  place  established  as  an  independent  entity  or  part  of  an  establishment  referred  to  in              

sub-clause  (i),  in  connection  with  the  diagnosis  or  treatment  of  diseases  where  pathological, 
bacteriological,  genetic,  radiological,  chemical,  biological  investigations  or  other  diagnostic  or 
investigative services with the aid of laboratory or other medical equipment, are usually carried 
on,  established  and  administered  or  maintained  by  any  person  or  body  of  persons,  whether 
incorporated or not, 

and shall include a clinical establishment owned, controlled or managed by— 

(a) the Government or a department of the Government; 

(b) a trust, whether public or private; 

(c) a corporation (including a society) registered under a Central, Provincial or State Act, whether 

or not owned by the Government; 

(d) a local authority; and 

(e) a single doctor, 

but does not include the clinical establishments owned, controlled or managed by the Armed Forces. 

Explanation.—For the purpose of this clause “Armed Forces” means the forces constituted under the 

Army  Act,  1950  (46  of  1950)  ,  the  Air  Force  Act,  1950  (45  of  1950)  and  the  Navy  Act,  1957                             
(62 of 1957); 

(d)  “emergency  medical  condition”  means  a  medical  condition  manifesting  itself  by  acute 
symptoms of sufficient severity (including severe pain) of such a nature that the absence of immediate 
medical attention could reasonably be expected to result in— 

(i) placing the health of the individual or, with respect to a pregnant women, the health of the 

woman or her unborn child, in serious jeopardy; or 

(ii) serious impairment to bodily functions; or 

(iii) serious dysfunction of any organ or part of a body; 

(e) “National Council” means the National Council for clinical establishments established under 

section 3; 

(f) “notification” means a notification published in the Official Gazette; 

(g) “prescribed” means prescribed by rules made under this Act by the Central Government or, as 

the case may be, the State Government; 

(h)  “recognised  system  of  medicine”  means  Allopathy,  Yoga,  Naturopathy,  Ayurveda, 
Homoeopathy,  Siddha  and  Unani  System  of  medicines  or any  other  system  of medicine  as  may  be 
recognised by the Central Government; 

(i) “register” means the register maintained by the authority, State Government and the Central 
Government under sections 37, 38 and 39 respectively of this Act containing the number of clinical 
establishments registered; 

(j) “registration” means to register under section 11 and the expression registration or registered 

shall be construed accordingly; 

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(k) “rules” means rules made under this Act; 

(l) “Schedule” means the Schedule appended to this Act; 

(m) “standards” means the conditions that the Central Government may prescribe under section 

12, for the registration of clinical establishments; 

(n)  “State  Government”,  in  relation  to  a  Union  territory,  means  the  Administrator  thereof 

appointed under article 239 of the Constitution; and 

(o) “to stabilise (with its grammatical variations and cognate expressions)” means, with respect to 
an  emergency  medical  condition  specified  in  clause  (d),  to  provide  such  medical  treatment  of  the 
condition  as  may  be  necessary  to  assure,  within  reasonable  medical  probability,  that  no  material 
deterioration  of  the  condition  is  likely  to  result  from  or  occur  during  the  transfer  of  the  individual 
from a clinical establishment. 

CHAPTER II 

THE NATIONAL COUNCIL FOR CLINICAL ESTABLISHMENTS 

3. Establishment of National Council.—(1) With effect from such date as the Central Government 
may,  by  notification  appoint  in  this  behalf,  there  shall  be  established  for  the  purposes  of  this  Act,  a 
Council to be called the National Council for clinical establishments. 

(2) The National Council shall consist of— 

(a) Director-General of Health Service, Ministry of Health and Family Welfare, ex officio, who 

shall be the Chairperson; 

(b) four representatives out of which one each to be elected by the— 

(i) Dental Council of India constituted under section 3 of the Dentists Act, 1948 (16 of 1948); 

(ii) Medical Council of India constituted under section 3 of the Indian Medical Council Act, 

1956 (102 of 1956); 

(iii) Nursing Council of India constituted under section 3 of the Indian Nursing Council Act, 

1947 (48 of 1947); 

(iv)  Pharmacy  Council  of  India  constituted  under  section  3  of  the  Pharmacy  Act,  1948                       

(8 of 1948); 

(c) three representatives to be elected by the Central Council of Indian Medicine representing the 
Ayurveda, Siddha and Unani systems of medicine constituted under section 3 of the Indian Medicine 
Central Council Act, 1970 (48 of 1970); 

(d)  one  representative  to  be  elected  by  the  Central  Council  of  Homoeopathy  constituted  under 

section 3 of the Homoeopathy Central Council Act, 1973 (59 of 1973); 

(e) one representative to be elected by the Central Council of the Indian Medical Association; 

(f) one representative of Bureau of the Indian Sandards constituted under section 3 of the Bureau 

of Indian Standards Act, 1986 (63 of 1986); 

(g)  two  representatives  from  the  Zonal  Council  set-up  under  section  15  of  the  States 

Reorganisation Act, 1956 (37 of 1956); 

(h)  two  representatives  from  the  North-Eastern  Council  set-up  under  section  3  of  the                

North-Eastern Council Act, 1971 (84 of 1971); 

(i)  one  representative  from  the  line  of  paramedical  systems  excluding  systems  that  have  been 

given representation under clause (b); 

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(j)  two  representatives  from  National  Level  Consumer  Group  to  be  nominated  by  the  Central 

Government; 

(k)  one  representative  from  the  Associations  of  Indian  Systems  of  Medicines  relating  to 

Ayurveda, Siddha and Unani to be nominated by the Central Government; 

(l) the Secretary-General of the Quality Council of India, ex officio. 

(3)  The  nominated  members  of  the  National  Council  shall  hold  office  for  three  years  but  shall  be 

eligible for re-nomination for maximum of one more term of three years. 

(4) The elected members of the National Council shall hold office for three years, but shall be eligible 

for re-election: 

Provided that the person nominated or elected, as the case may be, shall hold office for such period 

till he holds appointment of the office by virtue of which he was nominated or elected to the council. 

(5) The members of the National Council shall be entitled for such allowances as may be prescribed 

by the Central Government. 

(6)  The  National  Council  may,  subject  to  the  previous  approval  of  the  Central  Government,  make 
bye-laws  fixing  a  quorum  and  regulating  its  own  procedure  and  the  conduct  of  all  business  to  be 
transacted by it. 

(7) The National Council shall meet at least once in three months. 

(8) The National Council may constitute sub-committees and may appoint to such sub-committee, as 
it deems fit, persons, who are not members of the National Council, for such period, not exceeding two 
years, for the consideration of particular matters. 

(9) The functions of the National Council may be exercised notwithstanding any vacancy therein. 

(10) The Central Government shall appoint such person to be the Secretary of the National Council as 
the Central Government may prescribe, and may provide the National Council with such other secretarial 
and other staff as the Central Government considers necessary. 

4.  Disqualifications  for  appointment  as  member.—A  person  shall  be  disqualified  for  being 

appointed as a member of the National Council if he— 

(a) has been convicted and sentenced to imprisonment for an offence which, in the opinion of the 

Central Government, involves moral turpitude; or 

(b) is an undischarged insolvent; or 

(c) is of unsound mind and stands so declared by a competent court; or 

(d) has been removed or dismissed from the service of the Government or a Corporation owned or 

controlled by the Government; or 

(e) has, in the opinion of the Central Government, such financial or other interest in the Council as 

is likely to affect prejudicially the discharge by him of his functions as a member. 

5. Functions of National Council.—The National Council shall— 

(a) compile and publish a National Register of clinical establishments within two years from the 

date of the commencement of this Act; 

(b) classify the clinical establishments into different categories; 

(c) develop the minimum standards and their periodic review; 

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(d)  determine  within a  period  of two  years from  its establishment,  the  first  set of  standards for 

ensuring proper healthcare by the clinical establishments; 

(e) collect the statistics in respect of clinical establishments; 

(f) perform any other function determined by the Central Government from time to time. 

6. Power to seek advice or assistance.—The National Council may associate with itself any person 

or body whose assistance or advice it may desire in carrying out any of the provisions of this Act. 

7.  National  Council  to  follow  consultative  process.—The  National  Council  shall  follow  a 
consultative  process  for  determining  the  standards  and  for  classification  of  clinical  establishments  in 
accordance with such procedure as may be prescribed. 

REGISTRATION AND STANDARDS FOR CLINICAL ESTABLISHMENTS 

CHAPTER III 

8.  State  Council  of  clinical  establishments.—(1)  Every  State  Government  shall  by  notification 
constitute  a  State  Council  for  clinical  establishments  or  the  Union  territory  Council  for  clinical 
establishments, as the case may be. 

(2)  The  State  Council  or  the  Union  territory  Council,  as  the  case  may  be,  shall  consist  of  the 

following members, namely:— 

(a) Secretary, Health—ex officio, who shall be the Chairman; 

(b) Director of Health Services—ex officio member-secretary; 

(c) Directors of different streams of Indian Systems of Medicine—ex officio members; 

(d) one representative each to be elected by the executive committee of— 

(i) State Medical Council of India; 

(ii) State Dental Council of India; 

(iii) State Nursing Council of India; 

(iv) State Pharmacy Council of India; 

(e) three representatives to be elected by the Executive of the State Council or the Union territory 
Council,  as  the  case  may  be,  of  Indian  Medicine  representing  the  Ayurveda,  Siddha  and  Unani 
systems of medicine; 

(f) one representative to be elected by the State Council of the Indian Medical Association; 

(g) one representative from the line of paramedical systems; 

(h)  two  representatives  from  State  level  consumer  groups  or  reputed  non-Governmental 

organisations working in the field of health. 

(3) The nominated member of the State Council or the Union territory Council, as the case may be, 
shall  hold  office for a  term  of  three  years,  but  shall  be  eligible  for  re-nomination  for  maximum  of  one 
more term of three years. 

(4) The elected members of the State Council or the Union territory Council, as the case may be, shall 

hold office for three years, but shall be eligible for re-election: 

Provided that the person nominated or elected, as the case may be, shall hold office for so long as he 
holds the appointment of the office by virtue of which he was nominated or elected to the State Council or 
the Union territory Council, as the case may be. 

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(5) The State Council or the Union territory Council shall perform the following functions, namely:— 

(a) compiling and updating the State Registers of clinical establishment; 

(b) sending monthly returns for updating the National Register; 

(c) representing the State in the National Council; 

(d) hearing of appeals against the orders of the authority; and 

(e) publication on annual basis a report on the state of implementation of standards within their 

respective States. 

9. Providing information to National Council.—It shall be the responsibility of the State Council 
for clinical establishments to compile and update the State Register of clinical establishments of the State 
and further to send monthly returns in digital format for updating the National Register. 

10. Authority for registration.—(1) The State Government shall, by notification, set-up an authority 
to  be  called  the  district  registering  authority  for  each  district  for  registration  of  clinical  establishments, 
with the following members, namely:— 

(a) District Collector— Chairperson; 

(b) District Health Officer—Convenor; 

(c)  three  members  with  such  qualifications  and  on  such  terms  and  conditions  as  may  be 

prescribed by the Central Government. 

(2) Notwithstanding anything contained in sub-section (1), for the purposes of provisional registration 
of clinical establishments under section 14, the District Health Officer or the Chief Medical Officer (by 
whatever name called) shall exercise the powers of the authority as per procedure that may be prescribed. 

11. Registration for clinical establishments.—No person shall run a clinical establishment unless it 

has been duly registered in accordance with the provisions of this Act. 

12. Condition for registration.—(1) For registration and continuation, every clinical establishment 

shall fulfil the following conditions, namely:— 

(i) the minimum standards of facilities and services as may be prescribed; 

(ii) the minimum requirement of personnel as may be prescribed; 

(iii) provisions for maintenance of records and reporting as may be prescribed; 

(iv) such other conditions as may be prescribed. 

(2) The clinical establishment shall undertake to provide within the staff and facilities available, such 
medical examination and treatment as may be required to stabilise the emergency  medical condition of 
any individual who comes or is brought to such clinical establishment. 

13. Classification of clinical establishments.—(1) Clinical establishment of different systems shall 

be classified into such categories, as may be prescribed by the Central Government, from time to time. 

(2)  Different  standards  may  be  prescribed  for  classification  of  different  categories  referred  to  in                 

sub-section (1): 

Provided that in prescribing the standards for clinical establishments, the Central Government shall 

have regard to the local conditions. 

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CHAPTER IV 

PROCEDURE FOR REGISTRATION 

14. Application for provisional certificate of registration.—(1) For the purposes of registration of 
the  clinical  establishment  under  section  10,  an  application  in  the  prescribed  proforma  along  with  the 
prescribed fee shall be made to the authority. 

(2) The application shall be filed in person or by post or online. 

(3) The application shall be made in such form and shall be accompanied by such details as may be 

prescribed under this Act or rules made thereunder. 

(4)  If  any  clinical  establishment  is  in  existence  at  the  time  of  the  commencement  of  this  Act,  an 
application for its registration shall be made within one year from the date of the commencement of this 
Act and a clinical establishment which comes into existence after commencement of this Act, shall apply 
for permanent registration within a period of six months from the date of its establishment. 

(5) If any clinical establishment is already registered under any existing law requiring registration of 

such establishments, even then it shall apply for registration as referred to in sub-section (1). 

15. Provisional certificate.—The authority shall, within a period of ten days from the date of receipt 
of  such  application,  grant  to  the  applicant  a  certificate  of  provisional  registration  in  such  form  and 
containing such particulars and such information, as may be prescribed. 

16. No inquiry prior to provisional registration.—(1) The authority shall not conduct any inquiry 

prior to the grant of provisional registration. 

(2) Notwithstanding the grant of the provisional certificate of registration, the authority shall, within a 
period of forty-five days from the grant of provisional registration, cause to be published in such manner, 
as may be prescribed, all particulars of the clinical establishment so registered provisionally. 

17. Validity of provisional registration.—Subject to the provisions of section 23, every provisional 
registration shall be valid to the last day of the twelfth month from the date of issue of the certificate of 
registration and such registration shall be renewable. 

18.  Display  of  certificate  of  registration.—The  certificate  shall  be  kept  affixed  in  a  conspicuous 
place  in  the  clinical  establishment  in  such  manner  so  as  to  be  visible  to  every  one  visiting  such 
establishment. 

19.  Duplicate  certificate.—In  case  the  certificate  is  lost,  destroyed,  mutilated  or  damaged,  the 
authority shall issue a duplicate certificate on the request of the clinical establishment and on the payment 
of such fees as may be prescribed. 

20. Certificate to be non-transferable.—(1) The certificate of registration shall be non-transferable. 

(2) In the event of change of ownership or management, the clinical establishment shall inform the 

authority of such change in such manner as may be prescribed. 

(3)  In  the  event  of  change  of  category,  or  location,  or  on  ceasing  to  function  as  a  clinical 
establishment, the certificate of registration in respect of such clinical establishment shall be surrendered 
to the authority and the clinical establishment shall apply afresh for grant of certificate of registration. 

21.  Publication  of  expiry  of  registration.—The  authority  shall  cause  to  be  published  within  such 
time and in such manner, as may be prescribed, the names of clinical establishments whose registration 
has expired. 

22. Renewal of registration.—The application for renewal of registration shall be made thirty days 
before the expiry of the validity of the certificate of provisional registration and, in case the application 

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for renewal is made after the expiry of the provisional registration, the authority shall allow renewal of 
registration on payment of such enhanced fees, as may be prescribed. 

23. Time limit for provisional registration.—Where the clinical establishments in respect of which 
standards have been notified by the Central Government, provisional registration shall not be granted or 
renewed beyond,— 

(i)  the  period  of  two  years  from  the  date  of  notification  of  the  standards  in  case  of  clinical 

establishments which came into existence before the commencement of this Act; 

(ii)  the  period  of  two  years  from  the  date  of  notification  of  the  standards  for  clinical 
establishments  which  come  into  existence  after  the  commencement  of  this  Act  but  before  the 
notification of the standards; and 

(iii) the period of six months from the date of notification of standards for clinical establishments 

which come into existence after standards have been notified. 

24. Application for permanent registration.—Application for permanent registration by a clinical 
establishment shall be made to the authority in such form and be accompanied by such fees, as may be 
prescribed. 

25.  Verification  of  application.—The  clinical  establishment  shall  submit  evidence  of  having 

complied with the prescribed minimum standards in such manner, as may be prescribed. 

26. Display of information for filing objections.—As soon as the clincial establishment submits the 
required evidence of having complied with the prescribed minimum standards, the authority shall cause to 
be displayed for information of the public at large and for filing objections, if any, in such manner, as may 
be prescribed, all evidence submitted by the clinical establishment of having complied with the prescribed 
minimum standards for a period of thirty days before processing for grant of permanent registration. 

27.  Communication  of  objections.—If  objections  are  received  within the  period  referred  to  in the 
preceding  section,  such  objections  shall  be  communicated  to  the  clinical  establishment  for  response 
within a period of forty-five days. 

28.  Standards  for  permanent  registration.—Permanent  registration  shall  be  granted  only  when  a 

clinical establishment fulfils the prescribed standards for registration by the Central Government. 

29.  Allowing  or  disallowing  of  registration.—The authority  shall  pass an  order  immediately  after 

the expiry of the prescribed period and within the next thirty days thereafter either— 

(a) allowing the application for permanent registration; or 

(b) disallowing the application: 

Provided  that  the  authority  shall  record  its  reasons,  if  it  disallows  an  application,  for  permanent 

registration. 

30.  Certificate  of  permanent  registration.—(1) The  authority  shall,  if it, allows  an  application  of 
the clinical establishment, issue a certificate of permanent registration in such form and containing such 
particulars, as may be prescribed. 

(2) The certificate shall be valid for a period of five years from the date of issue. 

(3) For the purposes of sub-section (1), the provisions of sections 18, 19, 20 and 21 shall also apply. 

(4) The applications for renewal of permanent registration shall be made within six months before the 
expiry of the validity of the certificate of permanent registration and, in case the application of renewal is 
not submitted within the stipulated period, the authority may allow renewal of registration on payment of 
such enhanced fees and penalties as may be prescribed. 

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31.  Fresh  application  for  permanent  registration.—The  disallowing  of  an  application  for 
permanent  registration  shall  not  debar  a  clinical  establishment  from  applying  afresh  for  permanent 
registration under section 24 and after providing such evidence, as may be required, of having rectified 
the deficiences on which grounds the earlier application was disallowed. 

32.  Cancellation  of  registration.—(1)  If,  at  any  time  after  any  clinical  establishment  has  been 

registered, the authority is satisfied that,— 

(a) the conditions of the registration are not being complied with; or 

(b) the person entrusted with the management of the clinical establishment has been convicted of 

an offence punishable under this Act,  

it may issue a notice to the clinical establishment to show cause within three months' time as to why its 
registration under this Act should not be cancelled for the reasons to be mentioned in the notice. 

(2) If after giving a reasonable opportunity to the clinical establishment, the authority is satisfied that 
there has been a breach of any of the provisions of this Act or the rules made thereunder, it may, by an 
order, without prejudice to any other action that it may take against such clinical establishment, cancel its 
registration. 

(3) Every order made under sub-section (2) shall take effect— 

(a) where no appeal has been preferred against such order immediately on the expiry of the period 

prescribed for such appeal; and 

(b) where such appeal has been preferred and it has been dismissed from the date of the order of 

such dismissal: 

Provided  that  the  authority,  after  cancellation  of  registration  for  reasons  to  be  recorded  in  writing, 
may restrain immediately the clinical establishment from carrying on if there is imminent danger to the 
health and safety of patients. 

33. Inspection of registered clinical establishments.—(1) The authority or an officer authorised by 
it  shall  have  the  right  to  cause  an  inspection  of,  or  inquiry  in  respect  of  any  registered  clinical 
establishment,  its  building,  laboratories  and  equipment  and  also  of  the  work  conducted  or  done  by  the 
clinical establishment, to be made by such multi-member inspection team as it may direct and to cause an 
inquiry  to  be  made  in  respect  of  any  other  matter  connected  with  the  clinical  establishment  and  that 
establishment shall be entitled to be represented thereat. 

(2)  The  authority  shall  communicate  to  the  clinical  establishment  the  views  of  that  authority  with 
reference to the results of such inspection or inquiry and may, after ascertaining the opinion of the clinical 
establishment thereon, advise that establishment upon the action to be taken. 

(3) The clinical establishment shall report to the authority, the action, if any, which is proposed to be 
taken or has been taken upon the results of such inspection or inquiry and such report shall be furnished 
within such time, as the authority may direct. 

(4) Where the clinical establishment does not, within a reasonable time, take action to the satisfaction 
of the authority, it may, after considering any explanation furnished or representation made by the clinical 
establishment, issue such directions within such time as indicated in the direction, as that authority deems 
fit, and the clinical establishment shall comply with such directions. 

34.  Power  to  enter.—The  authority  or  an  officer  authorised  by  it  may,  if  there  is  any  reason  to 
suspect  that  anyone  is  carrying  on  a  clinical  establishment  without  registration, enter  and  search  in  the 
manner prescribed, at any reasonable time and the clinical establishment, shall offer reasonable facilities 
for inspection or inquiry and be entitled to be represented thereat: 

11 

 
Provided  that  no  such  person  shall  enter  the  clinical  establishment  without  giving  notice  of  his 

intention to do so. 

35.  Levy  of  fee  by  State  Government.—The  State  Government  may  charge  fees  for  different 

categories of clinical establishments, as may be prescribed. 

36. Appeal.—(1) Any person, aggrieved by an order of the registering authority refusing to grant or 
renew a certificate of registration or revoking a certificate of registration may, in such manner and within 
such period as may be prescribed, prefer an appeal to the State Council: 

Provided that the State Council may entertain an appeal preferred after the expiry of the prescribed 
period if it is satisfied that the appellant was prevented by sufficient cause from preferring the appeal in 
time. 

(2) Every appeal under sub-section (1) shall be made in such form and be accompanied by such fee as 

may be prescribed. 

CHAPTER V 

REGISTER OF CLINICAL ESTABLISHMENTS 

37. Register of clinical establishments.—(1) The authority shall within a period of two years from 
its  establishment,  compile,  publish  and  maintain  in  digital  format  a  register  of  clinical  establishments, 
registered by it and it shall enter the particulars of the certificate so issued in a register to be maintained in 
such form and manner, as may be prescribed by the State Government. 

(2) Each authority, including any other authority set-up for the registration of clinical establishments 
under  any  other  law  for  the  time  being  in  force,  shall  supply  in  digital  format  to  the  State  Council  of 
clinical  establishments  a  copy  of  every  entry  made  in  the  register  of  clinical  establishments  in  such 
manner, as may be prescribed to ensure that the State Register is constantly up-to-date with the registers 
maintained by the registering authority in the State. 

38. Maintenance of State Register of clinical establishments.—(1) Every State Government shall 
maintain in digital and in such form and containing such particulars, as may be prescribed by the Central 
Government a register to be known as the State Register of clinical establishments in respect of clinical 
establishments of that State. 

(2) Every State Government shall supply in digital format to the Central Government, a copy of the 
State  Register  of  clinical  establishments  and  shall  inform  the  Central  Government  all  additions  to  and 
other amendments in such register made, for a particular month by the 15th day of the following month. 

39. Maintenance of National Register of clinical establishments.—The Central Government shall 
maintain  in  digital  format  an  All  India  Register  to  be  called  as  the  National  Register  of  clinical 
establishments that shall be an amalgam of the State Register of clinical establishments maintained by the 
State Governments and shall cause the same to be published in digital format. 

CHAPTER VI 

PENALTIES 

40.  Penalty.—Whoever  contravenes  any  provision  of  this  Act  shall,  if  no  penalty  is  provided 
elsewhere, be punishable for the first offence with fine which may extend to ten thousand rupees, for any 
second offence with fine which may extend to fifty thousand rupees and for any subsequent offence with 
fine which may extend to five lakh rupees. 

12 

 
 
 
41.  Monetary  penalty  for  non-registration.—(1)  Whoever  carries  on  a  clinical  establishment 
without  registration  shall,  on  first  contravention,  be  liable  to  a  monetary  penalty  up  to  fifty  thousand 
rupees, for second contravention with a monetary penalty which may extend to two lakh rupees and for 
any subsequent contravention with a monetary penalty which may extend to five lakh rupees. 

(2) Whoever knowingly serves in a clinical establishment which is not duly registered under this Act, 

shall be liable to a monetary penalty which may extend to twenty-five thousand rupees. 

(3) For the purpose of adjudging under sub-sections (1) and (2), the authority shall hold an inquiry in 
the prescribed manner after giving any person concerned a reasonable opportunity of being heard for the 
purpose of imposing any monetary penalty. 

(4) While holding an inquiry the authority shall have power to summon and enforce the attendance of 
any person acquainted with the facts and circumstances of the case to give evidence or to produce any 
document which in the opinion of the authority, may be useful for or relevant to the subject matter of the 
inquiry  and  if,  on  such  inquiry,  it  is  satisfied  that  the  person  has  failed  to  comply  with  the  provisions 
specified  in  sub-sections  (1)  and  (2),  it  may  by  order  impose  the  monetary  penalty  specified  in  those                 
sub-sections to be deposited within thirty days of the order in the account referred to in sub-section (8) of 
section 42. 

(5)  While  determining  the  quantum  of  monetary  penalty,  the  authority  shall  take  into  account  the 
category,  size  and  type  of  the  clinical  establishment  and  local  conditions  of  the  area  in  which  the 
establishment is situated. 

(6) Any person aggrieved by the decision of the authority may prefer an appeal to the State Council 

within a period of three months from the date of the said decision. 

(7) The manner of filing the appeal referred to in sub-section (6) shall be such as may be prescribed. 

42.  Disobedience  of  direction,  obstruction  and  refusal  of  information.—(1)  Whoever  wilfully 
disobeys any direction lawfully given by any person or authority empowered under this Act to give such 
direction,  or  obstructs  any  person  or  authority  in  the  discharge  of  any  functions  which  such  person  or 
authority  is  required  or  empowered  under  this  Act  to  discharge,  shall  be  liable  to  a  monetary  penalty 
which may extend to five lakh rupees. 

(2) Whoever being required by or under this Act to supply any information wilfully withholds such 
information or gives information which he knows to be false or which he does not believe to be true, shall 
be liable to a monetary penalty which may extend to five lakh rupees. 

(3) For the purpose of adjudging under sub-sections (1) and (2), the authority shall hold an inquiry in 
the prescribed manner after giving any person concerned a reasonable opportunity of being heard for the 
purpose of imposing any monetary penalty. 

(4) While holding an inquiry the authority shall have power to summon and enforce the attendance of 
any person acquainted with the facts and circumstances of the case to give evidence or to produce any 
document which in the opinion of the authority, may be useful for or relevant to the subject matter of the 
inquiry  and  if,  on  such  inquiry,  it  is  satisfied  that  the  person  has  failed  to  comply  with  the  provisions 
specified  in  sub-sections  (1)  and  (2),  it  may  by  order  impose  the  monetary  penalty  specified  in  those                
sub-sections to be deposited within thirty days of the order in the account referred to in sub-section (8). 

(5)  While  determining  the  quantum  of  monetary  penalty,  the  authority  shall  take  into  account  the 
category,  size  and  type  of  the  clinical  establishment  and  local  conditions  of  the  area  in  which  the 
establishment is situated. 

(6) Any person aggrieved by the decision of the authority may prefer an appeal to the State Council 

within a period of three months from the date of the said decision. 

(7) The manner of filing the appeal referred to in sub-section (6) shall be such as may be prescribed. 

13 

 
(8)  The  monetary  penalty  levied  under  sections  41  and  42  shall  be  credited  to  such  account  as  the 

State Government may by order specify in this behalf. 

43.  Penalty  for  minor  deficiencies.—Whoever  contravenes  any  provision  of  this  Act  or  any  rule 
made thereunder resulting in deficiencies that do not pose any imminent danger to the health and safety of 
any patient and can be rectified within a reasonable time, shall be punishable with fine which may extend 
to ten thousand rupees. 

44.  Contravention  by  companies.—(1)  Where  a  person  committing  contravention  of  any  of  the 
provisions of this Act or of any rule made thereunder is a company, every person who, at the time the 
contravention was committed, was in charge of, and was responsible to the company for the conduct of 
the business of the company, as well as the company, shall be deemed to be guilty of the contravention 
and shall be liable to fine: 

Provided  that  nothing  contained  in  this  sub-section  shall  render  any  such  person  liable  to  any 
punishment  if  he  proves  that  the  contravention  was  committed  without  his  knowledge  or  that  he  had 
exercised all due diligence to prevent the commission of such contravention. 

(2)  Notwithstanding  anything  contained  in  sub-section  (1),  where  a  contravention  of  any  of  the 
provisions of this Act or of any rule made thereunder has been committed by a company and it is proved 
that the contravention has taken place with the consent or connivance of, or is attributable to any neglect 
on the part of, any director, manager, secretary or other officer of the company, such director, manager, 
secretary or other officer shall also be deemed to be guilty of that contravention and shall be liable to fine. 

Explanation.—For the purpose of this section,— 

(a)  “company”  means  a  body  corporate  and  includes  a  firm  or  other  association  of 

individuals; and 

(b) “director”, in relation to a firm, means a partner in the firm. 

45.  Offences  by  Government  Departments.—(1)  Where  an  offence  under  this  Act  has  been 
committed by any Department of Government within a period of six months after the commencement of 
this Act, the Head of the Department shall be deemed to be guilty of the offence and shall be liable to be 
proceeded against and punished accordingly: 

Provided that nothing contained in this section shall render such Head of the Department liable to any 
punishment if he proves that the offence was committed without his knowledge or that he exercised all 
due diligence to prevent the commission of such offence. 

(2) Notwithstanding anything contained in sub-section (1), where an offence under this Act has been 
committed by a Department of Government and it is proved that the offence has been committed with the 
consent or connivance of, or is attributable to any neglect on the part of, any officer, other than the Head 
of the Department, such officer shall also be deemed to be guilty of that offence and shall be liable to be 
proceeded against and punished accordingly. 

46. Recovery of fine.—Whoever fails to pay the fine, the State Council of clinical establishment may 
prepare a certificate signed by an officer authorised by it specifying the fine due from such person and 
send it to the Collector of the District in which such person owns any property or resides or carries on his 
business and the said Collector, on receipt of such certificate, shall proceed to recover from such person 
the amount specified thereunder, as if it were an arrear of land revenue. 

CHAPTER VII 

MISCELLANEOUS 

47. Protection of action taken in good faith.—(1) No suit, prosecution or other legal proceedings 
shall  lie  against  any  authority  or  any  member  of  the  National  Council  or  State  Council  or  any  officer 

14 

 
authorised  in  this  behalf  in  respect  of  anything,  which  is  in  good  faith  done  or  intended  to  be  done  in 
pursuance of the provisions of this Act or any rule made thereunder. 

(2) No suit or other legal proceedings shall lie against a State Government or the Central Government 
in respect of any loss or damage caused or likely to be caused by anything which is in good faith done or 
intended to be done in pursuance of the provisions of this Act or any rule made thereunder. 

48. Furnishing of returns, etc.—Every clinical establishment shall, within such time or within such 
extended time,  as  may  be  prescribed in  that  behalf, furnish  to the  authority  or  the  State  Council  or the 
National Council such returns or the statistics and other information in such manner, as may be prescribed 
by the State Government, from time to time. 

49.  Power  to  give  directions.—Without  prejudice  to  the  foregoing  provisions  of  this  Act,  the 
authority shall have the power to issue such directions, including furnishing returns, statistics and other 
information for the proper functioning of clinical establishments and such directions shall be binding. 

50. Employees of the authority, etc., to be public servants.—Every employee of the authority, the 
National Council and the State Council shall be deemed to, when acting or purporting to act in pursuance 
of  any  of  the  provisions  of  this  Act,  be public  servants  within the  meaning  of  section  21  of  the  Indian 
Penal Code (45 of 1860). 

51. Power to remove difficulties.—(1) If any difficulty arises in giving effect to the provisions of 
this Act, the Central Government may, by order published in the Official Gazette, make such provisions 
not  inconsistent  with  the  provisions  of  this  Act  as  may  appear  to  it  to  be  necessary  or  expedient  for 
removal of the difficulty: 

Provided that no such order shall be made after the expiry of a period of two years from the date of 

commencement of this Act. 

(2) Every order made under this section shall, as soon as may be after it is made, be laid before each 

House of Parliament. 

52.  Power  of  Central  Government  to  make  rules.—(1)  The  Central  Government  may,  by 

notification, make rules for carrying out all or any of the provisions of this Act. 

(2)  In  particular  and  without  prejudice  to  the  generality  of  the  foregoing  power,  such  rules  may 

provide for all or any of the following matters, namely:— 

(a) allowances for the members of the National Council under sub-section (5) of section 3; 

(b)  appointment  of  such  person  to  be  the  Secretary  of  the  State  Council  by  the  Central 

Government under sub-section (10) of section 3; 

(c) the determination of standards and for classification of clinical establishments under section 7; 

(d) the qualification and the terms and conditions for the members of the authority under clause 

(c) of sub-section (1) of section 10; 

(e) the procedure under which the powers of the authority may be exercised by the District Health 
Officer or Chief Medical Officer for the purpose of provisional registration of clinical establishment 
under sub-section (2) of section 10; 

(f) the minimum standards of facilities and services under clause (i) of sub-section (1) of section 

12; 

(g) the minimum number of personnel under clause (ii) of sub-section (1) of section 12; 

(h)  the  maintenance  of  records  and  reporting  by  the  clinical  establishment  under  clause  (iii)  of 

sub-section (1) of section 12; 

15 

 
(i) other conditions for registration and continuation of clinical establishment under clause (iv) of 

sub-section (1) of section 12; 

(j) classification of clinical establishment under sub-section (1) of section 13; 

(k)  the  different  standards  for  classification  of  clinical  establishments  under  sub-section  (2)  of 

section 13; 

(l) the minimum standards for permanent registration under section 28; 

(m) the form and particulars to be contained in the register to be maintained under section 38. 

53. Laying of rules.—Every rule made by the Central Government under this Act shall be laid, as 
soon as may be after it is made, before each House of Parliament, while it is in session, for a total period 
of thirty days which may be comprised in one session or in two or more successive sessions and if, before 
the  expiry  of  the  session  immediately  following  the  session  or  the  successive  sessions  aforesaid,  both 
Houses  agree  in  making  any  modification  in  the  rule  or  both  Houses  agree  that  the  rule  should  not  be 
made, the rule shall thereafter have effect only in such modified form or be of no effect, as the case may 
be;  so,  however,  that  any  such  modification  or  annulment  shall  be  without  prejudice  to  the  validity  of 
anything previously done under that rule. 

54. Power of State Government to make rules.—(1) The State Government may, by notification, 

make rules for carrying out in respect of matters which do not fall within the purview of section 52. 

(2)  In  particular  and  without  prejudice  to  the  generality  of  the  foregoing  power,  such  rules  may 

provide for all or any of the following matters, namely:— 

(a) the proforma and the fee to be paid for registration under sub-section (1) of section 14; 

(b) the form and details of application under sub-section (3) of section 14; 

(c)  the  particulars  and  information  contained  in  certificate  of  provisional  registration  under 

section 15; 

(d)  the  manner  of  publication  of  all  particulars  of  the  clinical  establishments  proposed  to  be 

registered under sub-section (2) of section 16; 

(e) the fees to be paid to issue a duplicate certificate under section 19; 

(f) the change of ownership or management to be informed by the clinical establishment to the 

authority under sub-section (2) of section 20; 

(g) the manner in which the authority shall publish the names of the clinical establishments whose 

registration expired under section 21; 

(h) the enhanced fees to be charged for renewal after expiry of the provisional registration under 

section 22; 

(i) the form of the application and fees to be charged by the State Government under section 24; 

(j)  the  manner  of  submitting  evidence  of  the  clinical  establishments  having  complied  with  the 

minimum standards under section 25; 

(k) the manner of displaying information of the clinical establishments having complied with the 

minimum standards for filing objection under section 26; 

(l) the expiry of period specified in section 29; 

(m) the form and particulars of the certificate of registration under section 30; 

(n)  the  period  within  which  an  appeal  shall  be  preferred  under  clause  (a)  of  sub-section  (3)  of 

section 32; 

16 

 
(o) the manner of entry and search of clinical establishment under section 34; 

(p)  the  fees  to  be  charged  by  the  State  Government  for  different  categories  of  clinical 

establishments under section 35; 

(q) the manner and the period within which an appeal may be preferred to the State Council under 

sub-section (1) of section 36; 

(r) the form and the fee to be paid for an appeal under sub-section (2) of section 36; 

(s)  the  form  and  the  manner  in  which  the  register  to  be  maintained  under  sub-section  (1)  of 

section 37; 

(t) the manner of supply to the State Council in digital format the entry made in the register of 

clinical establishment under sub-section (2) of section 37; 

(u) the manner of holding an inquiry by the authority under sub-section (3) of sections 41 and 42; 

(v) the manner of filing the appeal under sub-section (7) of sections 41 and 42; 

(w) the manner and the time within which the information is to be furnished to the authority or the 

State Council or the National Council as the case may be, under section 48; 

(x) any other matter which is required to be or may be prescribed by the State Government. 

55. Laying of rules.—Every rule made by the State Government under this section shall be laid, as 
soon  as  may  be  after  it  is  made,  before  each  House  of  the  State  Legislature  where  it  consists  of  two 
Houses, or where such Legislature consists of one House, before that House. 

56.  Savings.—(1) The  provisions  of  this  Act  shall  not  apply  to  the  States  in  which  the  enactments 

specified in the Schedule are applicable: 

Provided  that  the  States  in  which  the  enactments  referred  to  in  sub-section  (1)  are  applicable,  and 
such States subsequent to the commencement of this Act, adopts this Act under clause (1) of article 252 
of the Constitution, the provisions of this Act shall, subsequent to such adoption, apply in that State. 

(2)  The  Central  Government  may,  as  and  when  consider  necessary,  by  notification  amend  the 

Schedule. 

17 

 
 
 
THE SCHEDULE 

[See section 56] 

1. The Andhra Pradesh Private Medical Care Establishments (Registration and Regulation) Act, 2002. 

2. The Bombay Nursing Homes Registration Act, 1949. 

3. The Delhi Nursing Homes Registration Act, 1953. 

4.  The  Madhya  Pradesh  Upcharya  Griha  Tatha  Rujopchar  Sanbabdu  Sthapamaue  (Ragistrikaran 

Tatha Anugyapan) Adhiniyam, 1973. 

5. The Manipur Homes and Clinics Registration Act, 1992. 

6. The Nagaland Health Care Establishments Act, 1997. 

7. The Orissa Clinical Establishments (Control and Regulation) Act, 1990. 

8. The Punjab State Nursing Home Registration Act, 1991. 

9. The West Bengal Clinical Establishments Act, 1950. 

18 

 
